Background: The aim of this study was to evaluate the effect of ringer lactat solution on postoperative nausea and vomiting in adenoidectomy surgeries
Methode: This double blined randomized clinical study was performed on 100 patients with American society anesthesia physical classification system (ASA) 1 or 2 aged 15-40 yr, were allocated for elective adenoidectomy surgery. The patients were randomized in two group according to type of preoperative hydration, 20 cc/kg lactated ringer's solution for R group and 20cc/kg 5% dextrose water solution for D group.All patients with history of diabtes mellitus, opiate addiction, smoking, motion sickness, intake of antiemetic or psychotic drugs, postoperative nausea and vomiting (PONV) after previous surgeries, and positive familial history of PONV, were excluded from this study. In this study postoperative nausea and vomiting was assessed for the last 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111121383N3
Registration date:2016-03-10, 1394/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-10, 1394/12/20
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2015-05-07, 1394/02/17
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of hydration with ringer lactat and 5% dextrose solution on nausea and vomiting after adenotonsilectomy surgeries.
Public title
The effect of hydration with ringer lactat on post operative nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 100 patients with American society anesthesia physical classification system (ASA) 1 or 2, aged 15-40 yr, were allocated for elective adenoidectomy surgery.
Exclusion criteria: All patients with history of diabtes mellitus, opiate addiction, smoking, motion sickness, intake of antiemetic or psychotic drugs, postoperative nausea and vomiting (PONV) after previous surgeries, and positive familial history of PONV, were excluded from this study.
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
95
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand unviersity of medical sciences
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Postal code
9717853577
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
IR.BUMS.1394.36
Health conditions studied
1
Description of health condition studied
postoperative nausea and vomiting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of postoperative nausea and vomiting
Timepoint
Immediately after the end of the surgery, 0-2 h, 2-12 h, 12-24 h after surgery
Method of measurement
Incidence of nausea and vomiting during the first 24 hour after surgery.
Secondary outcomes
1
Description
Severity of nausea
Timepoint
Immediately after the end of surgery and at 0 – 2 h, 2 – 6 h and 6 – 24 h postsurgery.
Method of measurement
according to a visual analogue scale (VAS; 0, no nausea; 10, worst nausea)
2
Description
Need for rescue medication from nausea and vomiting.
Timepoint
Immediately after the end of surgery and at 0 – 2 h, 2 – 6 h and 6 – 24 h postsurgery.
Method of measurement
incidence of need for rescue medication from nausea and vomiting.
Intervention groups
1
Description
ringer lactat 20 ml per kilogeram from 24 hours before to end of the surgery
Category
Prevention
2
Description
dextrose 5% 20 ml per kilogeram from 24 hours before to end of the surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital of birjand university of medical sciences
Full name of responsible person
Dr. Amir Saber Tanha, anesthesiologist/ assistant professor
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Asghar Zarban
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand Unviersity of Medical Sciences
Full name of responsible person
Samaneh kouzegaran
Position
Assisstant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Postal code
Phone
Fax
Email
amirsaber63@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)